Skip to main content
OpenTrials
Completed

NCT Number: NCT03612115

Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension

This study aimed to investigate the effects of neuromuscular electrical stimulation on peripheral muscles and other physical and psychosocial variables in patients with pulmonary arterial hypertension. This study was designed as an assessor-blind randomized controlled trial. Thirty-one patients with pulmonary arterial hypertension will be recruited. The participants will randomly divided two parallel groups as treatment and control. For the treatment group, neuromuscular electrical stimulation will be applied to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks. Control group will not be received any additional treatment, just given healthy life recommendations such as walking. The participants will be assessed before and after the treatment by a blind assessor to the group allocation. The outcome measure will be assessments of the upper and lower limb muscle strength, respiratory muscle strength, muscle cross-sectional area and thickness, pulse wave velocity, exercise capacity, walking speed, functional mobility and balance performances, balance confidence, fatigue perceptions, physical activity level, activities of daily living and quality of life.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylül University

Izmir, 35320, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elevated pulmonary artery pressures measured by right heart catheterization
  • New York Heart Association class II or III
  • Stabile Pulmonary Arterial Hypertension-specific pharmaceutical therapy for 3 months

Exclusion criteria

  • Orthopaedic problems
  • Significant restrictive or obstructive pulmonary disease
  • Acute cor pulmonale.

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

Neuromuscular electrical stimulation to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks.

Device name: Four-channel Wireless Professional (DJO United Kingdom Ltd., Chattanooga, France)

Primary outcomes

  1. Isometric muscle strength

    Time frame: Change from Baseline at 8 weeks

    Isometric muscle strength for knee extensors

Secondary outcomes

  1. Isometric muscle strength

    Time frame: Change from Baseline at 8 weeks

    Isometric muscle strength for shoulder flexors and abductors

  2. Hand grip strength

    Time frame: Change from Baseline at 8 weeks

    Hand grip strength

  3. Quadriceps femoris muscle thickness

    Time frame: Change from Baseline at 8 weeks

  4. Rectus femoris cross-sectional area

    Time frame: Change from Baseline at 8 weeks

  5. Pulse wave velocity

    Time frame: Change from Baseline at 8 weeks

  6. Six-Minute Walk Test

    Time frame: Change from Baseline at 8 weeks

  7. Six-Minute Pegboard and Ring Test

    Time frame: Change from Baseline at 8 weeks

  8. Sit-to-Stand Test

    Time frame: Change from Baseline at 8 weeks

  9. Timed-Up and Go Test

    Time frame: Change from Baseline at 8 weeks

  10. Activities-specific Balance Confidence Scale

    Time frame: Change from Baseline at 8 weeks

    The Activities-specific Balance Confidence Scale is a 16-item instrument designed to measure a patient's perceived level of confidence in performing common activities of daily living without losing balance and falling. The patient ranks his confidence to complete each item from 0% (no confidence) to 100% (complete confidence). Total score is calculated as sum score ranged from 0 to 100. Higher scores indicate higher balance confidence level.

  11. 4-m Gait Speed Test

    Time frame: Change from Baseline at 8 weeks

  12. Fatigue Impact Scale

    Time frame: Change from Baseline at 8 weeks

    The Fatigue Impact Scale is widely used to measure fatigue. It is a 40-item multidimensional scale measuring the physical, cognitive and social. Patients are asked to rate how much of a problem fatigue has caused them during the past month, including the day of testing, on a 5-point Likert-type scale, with response options ranging from 0 "no problem" to 4 "extreme problem". Higher scores indicate the greater level of fatigue (total score ranged from 0 to 160).

  13. International Physical Activity Questionnaire-Short Form

    Time frame: Change from Baseline at 8 weeks

    The International Physical Activity Questionnaire-Short Form has 7 items listing activities and requests estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known metabolic equivalents per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. Higher scores indicate higher physical activity level.

  14. Milliken Activities of Daily Living Scale

    Time frame: Change from Baseline at 8 weeks

    Milliken Activities of Daily Living Scale consists of 47 items including preparing meals, and eating (8 items), self-care (9 items), dressing oneself (8 items), manual manipulation of objects (9 items), house cleaning, and washing clothes (7 items), and other activities (6 items). For scoring the level of ability to perform each item, a 5-point scale, and for the level of necessity to perform these items, a 3-point scale is used. Total score can range from 0 to 705 points. Higher scores indicate less limitation in activities of daily living.

  15. Nottingham Health Profile

    Time frame: Change from Baseline at 8 weeks

    Health-related quality of life will be assessed using Nottingham Health Profile scale which is a general quality of life questionnaire that measures perceived health problems and their impact on normal daily activities. It has 38 items divided into six domains: energy level, pain, emotional reactions, sleep, social isolation and physical abilities. Items use yes/no answer format and each item is weighted. Total scores for each domain range from 0 to 100. Higher scores represent less quality of life in relevant domain.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

Investigation of the Effects of Neuromuscular Electrical Stimulation in Patients With Pulmonary Arterial Hypertension

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2018
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.